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DMR RFP-265 3.3 V-16 07-Mar-2018
English
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Carefully read all instructions prior to use. Observe all contraindications,
warnings and precautions noted in these instructions. Failure to do so
may result in patient complications.
Caution:
Federal (U.S.A.) law restricts this device to sale by or on the
order of a physician.
I.
DEVICE DESCRIPTION
The Nykanen Radiofrequency Wire delivers radiofrequency (RF) power
in a monopolar mode between its distal electrode and a commercially
available external Disposable Indifferent (Dispersive) Patch (DIP)
Electrode, which is in compliance with IEC 60601-2-2. The Nykanen
Wire is connected to the BMC Radiofrequency Puncture Generator via
the BMC Catheter Connector Cable. Detailed information concerning the
BMC Radiofrequency Puncture Generator is contained in a separate
manual that accompanies the Generator (entitled “BMC Radiofrequency
Puncture Generator Instructions for Use”). Generators compatible with
the Nykanen Radiofrequency Wire include the RFP-100 or RFP-100A.
The critical dimensions of the Nykanen Wire can be found on the device
label. The Teflon insulation on the wire body facilitates smooth
advancement through guiding catheters, while the outer diameter is
small enough to provide adequate spacing for injection of contrast
solution through the guiding catheter. The distal portion of the Nykanen
Wire is flexible and the active tip specially shaped to be atraumatic to
the cardiac tissue unless RF energy is applied.
II.
INDICATIONS FOR USE
U.S.A.: The Nykanen Radiofrequency Wire is intended to cut and/or
coagulate soft tissues.
Canada: The Nykanen Radiofrequency Wire is intended to create an
atrial septal defect in the heart.
European Union (EU): The Nykanen Radiofrequency Wire is intended to
create an atrial septal defect in the heart. The Nykanen Radiofrequency
Wire is also intended to create a controlled perforation in heart tissue.
III.
CONTRAINDICATIONS
U.S.A.: The Nykanen Radiofrequency Wire is not recommended for use
with any conditions that do not require cutting or coagulation of soft
tissues.
Canada and EU: The Nykanen Radiofrequency Wire is not
recommended for use with any conditions that do not require the
creation of an atrial septal defect.
IV.
WARNINGS
The Nykanen Wire is supplied STERILE using an ethylene oxide
process. Do not use if the package is damaged.
Laboratory staff and patients can undergo significant x-ray
exposure during radiofrequency puncture procedures due to the
continuous usage of fluoroscopic imaging. This exposure can
result in acute radiation injury as well as increased risk for somatic
and genetic effects. Therefore, adequate measures must be taken
to minimize this exposure.
The Nykanen Wire is intended for single patient use only. Do not
attempt to sterilize and reuse the wire. Reuse can cause the
patient injury and/or the communication of infectious disease(s)
from one patient to another. Failure to do so may result in patient
complications.
The Nykanen Wire must be used with the BMC Catheter Connector
Cable. Attempts to use it with other connector wires can result in
electrocution of the patient and/or operator.
The active tip of the Nykanen Wire is fragile. Be careful not to
damage the tip while handling the wire. If the tip becomes
damaged discard the wire immediately.
If the active tip of the wire becomes bent at any time during its use,
dispose of the wire immediately. Do not attempt to straighten the
active tip.
For RFP-100: Do not attempt to puncture with an initial power
setting of greater than 10 watts. The initial attempt should be made
with a 10 watts setting. In subsequent attempts, the power setting
can be increased, if necessary.
The RF Puncture Wire is not intended for use with neonatal patients
(less than one month of age). Do not attempt to treat neonatal
patients with the wire.
V.
PRECAUTIONS
Do not attempt to use the Nykanen Radiofrequency Wire or
ancillary equipment before thoroughly reading the accompanying
Instructions for Use.
Radiofrequency puncture procedures should be performed only by
physicians thoroughly trained in the techniques of radiofrequency
powered puncture in a fully equipped catheterization laboratory.
The sterile packaging should be visually inspected prior to use to
detect any compromise. Ensure that the packaging has not been
damaged. Do not use the equipment if the packaging has been
compromised.
Visually inspect the Nykanen Wire prior to use to ensure there is
no cracking or damage to the insulating material. Do not use the
wire if there is any damage.
Do not use the Nykanen Wire a
fter the “Use By” date indicated on
the label.
The Nykanen Radiofrequency Wire is intended for use with only
those devices listed in section VIII, “Equipment Required.”
Read and follow the manufacturer’s instructions for use of the
Disposable Indifferent (Dispersive) Patch (DIP) electrode. Always
use DIP electrodes that meet or exceed IEC 60601-2-2
requirements.
Placement of the dispersive electrode on the thigh could be
associated with higher impedance.
In order to prevent the risk of ignition make sure that flammable
material is not present in the room during RF power application.
Take precautions to limit the effects that the electromagnetic
interference (EMI) produced by the Generator may have on the
performance of other equipment. Check the compatibility and
safety of combinations of other physiological monitoring and
electrical apparatus to be used on the patient in addition to the
Generator.
Adequate filtering must be used to allow continuous monitoring of
the surface electrocardiogram (ECG) during radiofrequency power
applications.
Careful wire manipulation must be performed to avoid cardiac
damage, or tamponade. Wire advancement should be done under
fluoroscopic guidance. If resistance is encountered, DO NOT use
excessive force to advance or withdraw the wire.
Do not attempt to puncture until firm position of the active tip has
been achieved against the atrial septum.
Do not activate RF while tip is within a third party catheter (if
using).
It is recommended not to exceed five (5) radiofrequency power
applications per Nykanen Wire.
Do not bend the Nykanen Wire. Excessive bending or kinking of
the wire shaft may damage the integrity of the wire and may cause
patient injury. Care must be taken when handling the wire.
The Generator is capable of delivering significant electrical power.
Patient or operator injury can result from improper handling of the
wire and DIP electrode, particularly when operating the device.
During power delivery, the patient should not be allowed to come
in contact with ground metal surfaces.
Apparent low power output or failure of the equipment to function
properly at normal settings may indicate faulty application of the
DIP electrode, failure to an electrical lead, or poor tissue contact
at the active tip. Check for obvious equipment defects or
misapplication. Attempt to better position the tip of the Nykanen
Wire against the atrial septum. Only increase the power if low
power output persists.
Regularly inspect and test re-usable cables and accessories.
Baylis Medical Company relies on the physician to determine,
assess and communicate to each individual patient all foreseeable
risks of the Baylis Medical Radiofrequency Puncture System.
VI.
ADVERSE EVENTS
Adverse events which may occur while using the Baylis Medical
Radiofrequency Puncture System include:
Atrial Fibrillation
Ventricular Tachycardia
Atrial Flutter
Perforation of the myocardium
Myocardial Infarction
Tamponade
Sustained Arrhythmia
VII.
INSPECTION PRIOR TO USE
Prior to use of the Baylis Medical Radiofrequency Puncture System, the
individual components including the BMC Radiofrequency Puncture
Generator, Nykanen Radiofrequency Wire, and the BMC Catheter
Connector Cable should be carefully examined for damage or defects,
as should all equipment used in the procedure. Do not use defective
equipment. Do not reuse the Nykanen Radiofrequency Wire.
VIII.
EQUIPMENT REQUIRED
Intracardiac puncture procedures should be performed in a specialized
clinical setting equipped with a fluoroscopy unit, radiographic table,